Safety

Safety and tolerability of PLAVIX was studied in controlled clinical trials involving over 42,000 patients.

PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. 13

In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). 17

For more information on safety in each trial, use the links below or please scroll below:

PLAVIX Monotherapy
CAPRIE Trial

PLAVIX with Aspirin
CURE Trial
COMMIT Trial
CLARITY Trial

PLAVIX Monotherapy

CAPRIE Trial

In the CAPRIE trial, the incidence of peptic, gastric, or duodenal ulcers was 0.7% for
PLAVIX and 1.2% for aspirin. 18

CAPRIE Trial

CAPRIE Trial

PLAVIX with Aspirin

CURE Trial

In the CURE Trial, the rates of major and minor bleeding were higher in patients who were treated using PLAVIX with aspirin compared to patients who were treated using the placebo with aspirin. 13

CURE Trial

  • The increase in major bleeding was dose-dependent on aspirin:.

<100 mg (2.6% vs 2.0%); 100 mg — 200 mg (3.5% vs 2.3%); >200 mg (4.9% vs 4.0%) 18

For more information on safety in the CURE trial, click here.

COMMIT Trial

In the COMMIT Trial, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups. 13

CURE Trial

  • 6% of patients in COMMIT were =70 years old 18
  • The relative rate of major noncerebral or cerebral bleeding was independent of age (event rates by age for PLAVIX + aspirin vs placebo + aspirin: <60=0.3% vs 0.4%; =60 to <70=0.7% vs 0.6%; =70=0.8% vs 0.7%) 18

For more information on safety in the COMMIT trial, click here.

CLARITY Trial

In the CLARITY Trial, the incidence of fatal bleeding and intracranial hemorrhage was low and similar in both groups. 18

CLARITY Trial

  • Major bleeding rates were consistent across subgroups and type of fibrinolytic or heparin therapy 18

For more information on safety in the CLARITY trial, click here.

Indications
–
Use PLAVIX plus aspirin for patients with non–ST–segment elevation acute coronary syndrome (UA/non–Q–wave MI), including patients to be managed medically and those to be managed with percutaneous coronary intervention (with or without stent) or CABG, to decrease the rate of a combined end point of CV death, MI, or stroke as well as the rate of a combined end point of CV death, MI, stroke, or refractory ischemia.

–
Use PLAVIX plus aspirin for patients with ST–segment elevation acute myocardial infarction to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

–
Use PLAVIX alone for patients with a history of recent stroke, recent MI, or established PAD to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Important Risk Information 18
–
PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*)

–
The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo
plus aspirin in clinical trials. (See ADVERSE REACTIONS.*)

–
Due to an expected reduction in drug levels and clinical efficacy, concomitant use of drugs that inhibit CYP2C19 (eg, omeprazole) should be discouraged. (See PRECAUTIONS.*)

–
As part of the worldwide post–marketing experience with PLAVIX, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). (See WARNINGS.*)

–
Based on literature, patients with genetically reduced CYP2C19 function have diminished responses and generally exhibit higher CV event rates following MI. (See PRECAUTIONS.*)

–
In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)